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Last Updated: May 24, 2024

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PREVYMIS Drug Patent Profile


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When do Prevymis patents expire, and when can generic versions of Prevymis launch?

Prevymis is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this drug.

This drug has ninety-four patent family members in forty-seven countries.

The generic ingredient in PREVYMIS is letermovir. One supplier is listed for this compound. Additional details are available on the letermovir profile page.

DrugPatentWatch® Generic Entry Outlook for Prevymis

Prevymis was eligible for patent challenges on November 8, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 5, 2030. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (letermovir), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for PREVYMIS
International Patents:94
US Patents:3
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 48
Clinical Trials: 7
Patent Applications: 127
Drug Prices: Drug price information for PREVYMIS
What excipients (inactive ingredients) are in PREVYMIS?PREVYMIS excipients list
DailyMed Link:PREVYMIS at DailyMed
Drug patent expirations by year for PREVYMIS
Drug Prices for PREVYMIS

See drug prices for PREVYMIS

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PREVYMIS
Generic Entry Dates for PREVYMIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for PREVYMIS*:
Constraining patent/regulatory exclusivity:
FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PREVYMIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Children's Oncology GroupPhase 3
Jean-Pierre RoutyN/A
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2

See all PREVYMIS clinical trials

US Patents and Regulatory Information for PREVYMIS

PREVYMIS is protected by three US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PREVYMIS is ⤷  Sign Up.

This potential generic entry date is based on FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PREVYMIS

Pharmaceutical composition containing an antivirally active dihydroquinazoline derivative
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted dihydroquinazolines
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted dihydroquinazolines
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting PREVYMIS

PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
Exclusivity Expiration: ⤷  Sign Up

EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE
Exclusivity Expiration: ⤷  Sign Up

FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
Exclusivity Expiration: ⤷  Sign Up

PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-001 Nov 8, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-001 Nov 8, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PREVYMIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-001 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-001 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for PREVYMIS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Prevymis letermovir EMEA/H/C/004536
Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Consideration should be given to official guidance on the appropriate use of antiviral agents.
Authorised no no yes 2018-01-08
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PREVYMIS

When does loss-of-exclusivity occur for PREVYMIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 13224947
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014020946
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 65203
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 14002306
Estimated Expiration: ⤷  Sign Up

China

Patent: 4144678
Estimated Expiration: ⤷  Sign Up

Patent: 0433166
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 61076
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0191369
Estimated Expiration: ⤷  Sign Up

Patent: 0240197
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 21910
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 19648
Estimated Expiration: ⤷  Sign Up

Patent: 56350
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 6584
Estimated Expiration: ⤷  Sign Up

Patent: 1400963
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 19648
Estimated Expiration: ⤷  Sign Up

Patent: 56350
Estimated Expiration: ⤷  Sign Up

Patent: 28218
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 56350
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2012101680
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 05462
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 45949
Estimated Expiration: ⤷  Sign Up

India

Patent: 92MUN2014
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 4363
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 87486
Estimated Expiration: ⤷  Sign Up

Patent: 15508801
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 19648
Estimated Expiration: ⤷  Sign Up

Patent: 56350
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 2310
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 9666
Estimated Expiration: ⤷  Sign Up

Patent: 14010364
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 448
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 941
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8444
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 014501937
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 19648
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 19648
Estimated Expiration: ⤷  Sign Up

Patent: 56350
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 157
Estimated Expiration: ⤷  Sign Up

Patent: 137
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201405294X
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 19648
Estimated Expiration: ⤷  Sign Up

Patent: 56350
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1405949
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2149561
Estimated Expiration: ⤷  Sign Up

Patent: 140130683
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 41698
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 14000345
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 1415
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREVYMIS around the world.

Country Patent Number Title Estimated Expiration
Denmark 2819648 ⤷  Sign Up
Canada 2865203 PREPARATION PHARMACEUTIQUE CONTENANT UN DERIVE DE DIHYDROCHINAZOLINE A ACTION ANTIVIRALE (PHARMACEUTICAL COMPOSITION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE) ⤷  Sign Up
Honduras 2004000146 DIHIDROQUINAZOLINAS SUSTITUIDAS ⤷  Sign Up
Israel 234363 תכשיר רוקחות המכיל נגזרת דיהידרוקוינאזולין עם פעילות אנטי-נגיפית (Pharmaceutical preparation containing an antivirally active dihydroquinazoline derivative) ⤷  Sign Up
Norway 2018022 ⤷  Sign Up
Montenegro 03448 FARMACEUTSKI PREPARAT КОЈI OBUHVATA ANTIVIRUSNO EFIKASAN DERIVAT DIHIDROHINAZOLINA (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY DIHYDROQUINAZOLINE DERIVATIVE) ⤷  Sign Up
Germany 10319612 Substituierte Dihydrochinazoline ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PREVYMIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1622880 C 2018 027 Romania ⤷  Sign Up PRODUCT NAME: LETERMOVIR SAU SAREA SA, SOLVATUL SAU, SAU SOLVATUL SARII SALE; NATIONAL AUTHORISATIONNUMBER: EU/1/17/1245; DATE OF NATIONAL AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EU ROPEAN ECONOMIC AREA (EEA): EU/1/17/1245; DATE OF FIRST AUTHORISATION IN EEA: 20180108
1622880 LUC00080 Luxembourg ⤷  Sign Up PRODUCT NAME: LETERMOVIR, OU UN SEL, SOLVATE OU SOLVATE DE SON SEL; AUTHORISATION NUMBER AND DATE: /EU/1/17/1245 20180110
1622880 28/2018 Austria ⤷  Sign Up PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; NAT. REGISTRATION NO/DATE: EU/1/17/1245/001 - EU/1/17/1245/004 (MITTEILUNG) 20180110; FIRST REGISTRATION: EU EU/1/17/1245/001 - EU/1/17/1245/004 20180110
1622880 2018C/015 Belgium ⤷  Sign Up PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU/1/17/1245 20180110
1622880 2018/026 Ireland ⤷  Sign Up PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE, OR SOLVATE OF ITS SALT.; REGISTRATION NO/DATE: EU/1/17/1245 20180108
1622880 300933 Netherlands ⤷  Sign Up PRODUCT NAME: LETERMOVIR; REGISTRATION NO/DATE: EU/1/17/1245 20180110
1622880 C20180020 00265 Estonia ⤷  Sign Up PRODUCT NAME: LETERMOVIIR;REG NO/DATE: EU/1/17/1245 10.01.2018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.